PRN Investigational Drug (IND) Specialist

About the Role

SCRI Oncology Partners, a leading cancer treatment practice in Nashville, Tenn., is seeking a PRN (As Needed) professional to provide consultative support and training for their pharmacy program, specifically related to Investigational Drug (IND) management. This role is crucial in ensuring compliance with regulatory standards and supporting the practice's commitment to advancing cancer therapies through clinical research.

Responsibilities

• Provides expertise in investigational drug accountability, inventory reconciliation, disposition, and destruction upon study closure.
• Reviews and reconciles investigational drug records, accountability logs, temperature monitoring documentation, and sponsor-required closeout documentation.
• Assists in identifying and resolving discrepancies related to investigational product inventory and documentation.
• Coordinates sponsor, monitor, and audit-related investigational drug closeout activities.
• Ensures compliance with protocol requirements, sponsor instructions, FDA regulations, GCP guidelines, and organizational policies.
• Develops and delivers training programs for pharmacists and pharmacy technicians on investigational drug management and closeout procedures.
• Creates educational materials, standard work documents, job aids, and competency assessments.
• Evaluates workflows and recommends process improvements for compliance, efficiency, and operational readiness.
• Assists with preparation for internal audits and regulatory inspections.
• Serves as a resource for pharmacy staff on investigational drug regulations, sponsor expectations, and best practices.
• Collaborates on quality assurance initiatives related to investigational drug services.
• Maintains current knowledge of FDA regulations, USP standards, GCP requirements, and investigational drug management practices.

Qualifications

• Minimum of High School Diploma in combination with required experience.
• Minimum 5 years of experience in oncology pharmacy, investigational drug services, research pharmacy, or clinical trial operations.
• Extensive knowledge of FDA regulations governing investigational drug management.
• Strong understanding of GCP guidelines, sponsor requirements, and research compliance standards.
• Experience with investigational drug accountability systems and documentation requirements.
• Knowledge of oncology clinical trials and investigational oncology agents preferred.
• Excellent communication, presentation, and training skills.
• Strong organizational and project management abilities.
• High attention to detail and accuracy.
• Ability to function independently and collaborate effectively with multidisciplinary teams.
• Proficiency in Microsoft Office applications and electronic research systems.

Working Conditions

This role operates in a traditional outpatient oncology clinic, pharmacy, and office environment. Occasional on-site support may be required during audits, monitor visits, or staff training sessions. Exposure to conditions common to an oncology practice and research environment is expected.

Physical Requirements

• Extended periods of computer-based work.
• Ability to review and organize investigational drug records and documentation.
• Occasional standing, walking, and lifting of study-related materials weighing up to 25 pounds.

Employment Status

This is a PRN (As Needed) position, providing intermittent expertise and operational support for investigational drug study closeout activities, pharmacy compliance reviews, staff education, competency validation, and process improvement initiatives. Hours will vary based on organizational needs, study volume, audit preparation activities, and training requirements.